The planning of a clinical trial can be complex and ECTU are able to provide support over the lifetime of the study, from the application process through to close down and reporting.
We would strongly recommend seeking advice early in the planning stage as the design, feasibility and costing of a proposal can take some time.
ECTU provides a comprehensive infrastructure reflecting the knowledge and expertise to design, develop and deliver a clinical trial. The key services are:
• Methodology and statistics
• Trial management
• Data management and programming
• Health economics
• Patient, carer and public involvement (PCPI) – delivered via https://www.ed.ac.uk/clinical-research-facility/patient-and-public-involvement
• Research management and business planning of awarded trials
• Quality assurance
What you can expect from ECTU
• Help design your clinical trial before funding application and supporting you through the application process.
• Provide you with a letter of support to the funder if required and once formal ECTU adoption of your clinical trial is confirmed.
• Work to Sponsor and ECTU SOPs.
• Develop study-specific working practice documents where required.
• Host the trial master file (TMF0, or sections of it, ensuring availability and readiness for Inspection if delegated.
• Advise you at the earliest opportunity of any issues which we consider will have a significant impact on trial progress.
• Review ECTU budgets closely to ensure quality and value for money.
• We will provide a table of responsibilities, which will outline tasks ETCU will deliver as part of the application process. This will impact on resources required to successfully deliver your clinical trial. Any changes to these tasks must be highlighted and agreed as this may impact on funds and resource use within ECTU.
What we can and cannot do
✔ Work with other institutions and/or organisations acting as the Study Sponsor. In order to do so they will need to provide a full suite of SOPs and required documents.
X We do not support monitoring or pharmacovigilance activities but can provide details of subcontractors should these functions be required.
X We cannot take responsibility for completing the SoECAT form, but we do expect to review this with you before submission.
Additional Information: ECTU Studies Within a Trial (SWATs)
We are keen to embed studies of clinical trial conduct / methodology within our trials. These are best designed and costed as part of the initial grant application, and there are various options for funding them. Possible ideas for such studies are listed at: http://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/SWATSWARInformation/Repositories/SWATStore/
For enquiries on accessing ECTU support please complete the online new proposal form.
Edinburgh Clinical Trials Unit
- Dr Agnes Tello, Snr Research Development Manager
- Email: ECTUemail@example.com
University of Edinburgh
level 2, NINE Edinburgh BioQuarter
9 Little France Road
- Post Code
- EH16 4UX
Ethical and Regulatory Approval
Useful Trial Planning Tools
|How to get your trial adopted and access support|
|Clinical Support||Trial Management||Statistical and Health Economics Support|